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Item Details
Title: FDA IN THE TWENTY-FIRST CENTURY
THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES
By: I. Glenn Cohen (Editor), Holly Fernandez Lynch (Editor)
Format: Hardback

List price: £62.00
Our price: £49.60
Discount:
20% off
You save: £12.40
ISBN 10: 0231171188
ISBN 13: 9780231171182
Availability: Usually dispatched within 1-3 weeks.
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Stock: Currently 0 available
Publisher: COLUMBIA UNIVERSITY PRESS
Pub. date: 8 September, 2015
Pages: 568
Description: The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Synopsis: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Publication: US
Imprint: Columbia University Press
Returns: Returnable
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